Supply of API, Excipients Sample Clauses

Supply of API, Excipients. AMAG shall supply Active Pharmaceutical Ingredients meeting the specifications set forth or referenced in ANNEX 1 for performance of the development and transfer Services, and for production of the Product hereunder. During the term of this Agreement, AMAG shall deliver API to DSM’s delivery site located at 0000 Xxxxxx Xxxxxx Xxxx Hwy, Greenville, NC 27834 (“Delivery Site”). DSM will supply Excipients and all other materials required to manufacture, test, package, label, and release the Product in accordance with the Firm Purchase Commitment; and such Excipients and other materials shall meet the specifications set forth in ANNEX 1. Packaging Specifications are also set forth or referenced in ANNEX 1.
Sample 1
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Supply of API, Excipients. OMEROS shall, at its sole discretion and as specified in Section 3 of Annex 1 (which Section may be amended from time to time by OMEROS upon at least ninety (90) days’ prior written notice to DSM), either (a) supply DSM with API meeting the API Specifications in accordance with this Section 4.2, or (b) require DSM to procure such API at OMEROS’ cost from vendors approved by OMEROS (which may be, but need not be, Approved Vendors or which may become Approved Vendors through qualification by DSM, at OMEROS’ cost in accordance with Section 4.4). For each shipment of API supplied hereunder by OMEROS, OMEROS or its supplier shall provide DSM with an API Certificate of Analysis. DSM shall (i) perform identification, bacterial endotoxin and microbial limit testing on the API, including complete analysis to confirm compliance with the API Specifications for API intended for use in Manufacturing, and confirm the shipment quantity, as well as any other acceptance testing as may be reasonably requested by Omeros, and (ii) notify OMEROS of any inaccuracies with respect to quantity, any failure of any portion of the shipment to meet the acceptance testing reasonably requested by OMEROS, or of any claim that any portion of the shipment does not meet the applicable API Specifications, which testing and notification will, if requested by Omeros following delivery of the API, be completed within [†] days of such request. DSM’s use of the API or failure to provide the foregoing notice if requested by OMEROS within the foregoing [†] day time period (or, in the case of a Latent API Defect, promptly after the discovery thereof and in any event no later than the established shelf life of the API) shall be deemed acceptance of such API as conforming. In the event DSM notifies OMEROS of any deficiency in quantity of API supplied by OMEROS, including deficiencies resulting from non-conforming API, OMEROS shall use commercially reasonable efforts to promptly ship to DSM, at OMEROS’ expense, the quantity of API necessary to satisfy the shortfall within a sufficient period of time in advance of DSM’s scheduled production, unless DSM and OMEROS mutually agree to a reduction in Product quantity to be Manufactured in accordance with Section 7.1.2. Further, in the event that there are any deficiencies in the API supplied by OMEROS hereunder, the provisions of Section 4.4 shall apply equally to OMEROS if and to the extent they apply to Unapproved Vendors. DSM will supply Excipients and al...
Sample 1
Supply of API, Excipients. Discovery Labs shall supply Active Pharmaceutical Ingredients meeting the specifications set forth or referenced in ANNEX 1 for production of the Product hereunder. DSM will supply Excipients and all other materials required to manufacture, test, package, label, and release the Product; and such Excipients and other materials shall meet the specifications set forth in the applicable Product Addendum. Packaging Specifications are also set forth or referenced in ANNEX 1.
Sample 1
Supply of API, Excipients. Onyx shall supply Active Pharmaceutical Ingredients and Captisol® meeting the specifications set forth or referenced in ANNEX 1 for production of the Product hereunder. DSM will supply Excipients and all other Product Components required to manufacture, test, package, label, and Release the Product; and such Excipients and other Product Components shall meet the applicable Specifications set forth or referenced in ANNEX 1.
Sample 1

Related to Supply of API, Excipients

  • Supply of Products TheraSense shall be responsible for the ------------------ manufacture of FreeStyle Products for sale to Nipro.

  • Supply of Product The JDC shall be responsible for determining the sources of, and arrangements for, the manufacture and supply of Products that the JDC believes will result in long-term profit maximization for such Products. The JDC shall endeavor to [ * ].

  • Supply of Materials Unless the parties otherwise agree in a Work Order, Manufacturer will supply, in accordance with the relevant approved raw material specifications, all materials to be used by Manufacturer in the performance of Services under a Work Order other than the Rhythm Materials specified in such Work Order. Rhythm or its designees will provide Manufacturer with the Rhythm Materials. Manufacturer agrees (a) to account for all Rhythm Materials, (b) not to provide Rhythm Materials to any third party (other than an Affiliate acting as a permitted subcontractor) without the express prior written consent of Rhythm, (c) not to use Rhythm Materials for any purpose other than conducting the Services, including, without limitation, not to analyze, characterize, modify or reverse engineer any Rhythm Materials or take any action to determine the structure or composition of any Rhythm Materials unless required * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. pursuant to a signed Work Order, and (d) to destroy or return to Rhythm all unused quantities of Rhythm Materials according to Rhythm’s written directions.

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Packaging and Labeling 11.1 Company shall provide packaging and labeling specifications that call out clear labeling requirements.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Manufacture (a) Manufacturer shall only manufacture the specific number of Products as requested by Company and at no time shall manufacture excess goods or overruns. Manufacturer shall not sell any Products bearing the Trademarks to any third parties without the express written consent of Company.

  • Product The term “

  • Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

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